The U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing facility located at 1972 Republic Avenue, San Leandro, CA, March 4 – 11, 2013. Your firm manufactures, packages, labels, holds, and distributes dietary supplements. During the inspection, our investigator documented significant violations of FDA’s Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). The investigator documented observations on form FDA-483, Inspectional Observations, and discussed them with you when the form was issued to you at the conclusion of the inspection. Additionally, our investigators collected and reviewed samples of the labeling of your dietary supplement products during the inspection of your facility. In December 2013, we also reviewed labeling on your website at www.intensivenutrition.com. Based on our review of your product labeling, we have determined that your Tanalbit dietary supplement product is promoted for conditions that cause it to be a drug within the meaning of section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your labeling establish that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease.

Even if your Tanalbit product were not an unapproved new drug, your violations of 21 CFR Part 111 cause it and your Tabit dietary supplement product to be adulterated under Section 402(g)(1) of the Act [21 U.S.C. §342(g)(1)] in that the products have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.

Further, your Tabit dietary supplement product is misbranded under section 403 of the Act [21 U.S.C. § 343] because it does not comply with FDA’s labeling regulations under 21 CFR Part 101. In addition, if your Tanalbit dietary supplement product did not have disease claims, which make this product a drug, it would also be misbranded for the same reason.

We acknowledge receipt of your letter, dated March 27, 2013, concerning our investigator’s observations noted on the Form FDA 483, and address it below.

You may find the Act and the FDA’s regulations through links on FDA’s home page at http://www.fda.gov.

Unapproved New Drugs

Examples of some of the claims observed on the labels for your products include the following:

“Tanalbit and our other plant tannins function by adhering to the outer membrane of a yeast and/or bacterial cell…rendering the unwanted organism harmless…[i]n so doing, the unwanted yeast and/or bacteria dies and is digested out by your system.”

On your website, at the webpage www.intensivenutrition.com/products/tanalbit-plant-gi-support-product-120-capsules:

“As a consequence of the antioxidant potential of tannins [ingredients in your product Tanalbit], many studies have been performed indicating their potential as anticarcinogenic and antimutagenic compounds….”

“When to use Tanalbit: … For comprehensive target of GI; Use for yeast as well as bacteria; Suggested for systemic problems associated with yeast and/or bacteria overgrowth (GI is often the source of the problem thus eliminating the problem at its ‘source’…”

Your Tanalbit product is not generally recognized as safe and effective for the above referenced uses and therefore, the product is a “new drug” under section 201(p)(1) of the Act [21 U.S.C. §321(p)(1)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C §355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.

Dietary Supplement CGMP Violations

Even if your Tanalbit product did not have therapeutic claims which make it a drug, it is adulterated, as is your Tabit dietary supplement product, based on the following significant violations:

1. Your firm did not ensure that the tests or examinations you use to determine that you have met the established specifications are appropriate, scientifically valid methods, as required by 21 CFR 111.75(h)(1). Specifically, you use (b)(4) for all identity testing; however, your standard reference material is inappropriate because it is a previous lot of product for which identity has not been confirmed. A previous lot is not an acceptable standard unless it is adequately confirmed to be acceptable as a reference standard using scientifically valid methods.

2. Your firm failed to establish product specifications for the identity, purity, strength, and composition of the finished batch of each dietary supplement that you manufacture, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of dietary supplement products, as required by 21 CFR 111.70(e). Specifically, you failed to establish finished product specifications for purity, strength, and limits on heavy metal contaminants for your dietary supplement products. Your master formulas for your Tanalbit and Tabit dietary supplement products did not include specifications for purity and strength of the finished products, and you stated during the inspection that you have not established or documented finished product specifications for the purity and strength for any of your dietary supplement products. Further, you stated during the inspection that you have not established or documented limits for contaminants, such as heavy metals that may be present in soil in which botanical ingredients are grown, in your specifications for finished dietary supplements with botanical origins, including for Tanalbit capsules and Tabit capsules. Once you establish finished product specifications, you must verify that specifications are met, as required by 21 CFR 111.75(c).

We reviewed your response dated March 27, 2013, and have determined it is inadequate. Your response states that you “have created a specification form (see attachments 1A-1F) for [y]our finished products that will allow [you] to verify that finished products meet established specifications.” However, attachments 1A-1F appear to be forms for recording results of your product inspections. Attachments 1A-1F do not provide finished product specifications. Your response did not include any documentation that you have established finished product specifications for your dietary supplement products that could be used to verify their identity, purity, strength, and composition.

3. Your firm failed to establish component specifications that are necessary to ensure that specifications for the purity, strength and composition of dietary supplements manufactured using the components are met, and to establish limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.70(b)(2) and (3). Similarly, your firm failed to establish an identity specification for each component used in the manufacture of your dietary supplement products, as required by 21 CFR 111.70(b)(1). Specifically, you informed our investigator that the specifications for identity, purity, strength, and composition are not established and documented for raw materials, such as: (b)(4) used in the manufacturing of Tanalbit dietary supplement; and (b)(4) used in the manufacturing of Tabit dietary supplements.

We reviewed your response dated March 27, 2013, and have determined it is inadequate. Your response states that you “have established specifications for purity of incoming component materials (raw materials) via (b)(4) and established in process controls for raw material handling and release (see attachments 2A-2D).” However, attachments 2A-2D appear to be forms for recording results of your raw material inspections. Attachments 2A-2D do not provide component specifications. Your response did not include any documentation that you have established specifications for the above listed raw materials.

We note that in Attachment 4 of your response letter, you provided a letter that you are using to request your suppliers to verify the purity and strength of the raw material (component) supplied “[i]n order to comply with GMP regulations as defined by the FDA.” Once you establish specifications for your components, you must verify the identity of each component that is a dietary ingredient, as required by 21 CFR 111.75(a)(1)(i) (unless you successfully petition FDA for an exemption under 21 CFR 111.75(a)(1)(ii)), and confirm the identity of other components and determine whether the specifications that you have established for those components are met, as required by 21 CFR 111.75(a)(2). You may rely on a Certificate of Analysis from the supplier of a non-dietary ingredient component that you receive only under the conditions outlined in 21 CFR 111.75(a)(2)(ii). For components that are dietary ingredients, you may not rely on a Certificate of Analysis.

4. Your firm failed to establish in-process specifications for a point, step, or stage in the master manufacturing record where control is necessary to help ensure that specifications are met for the identity, purity, strength, and composition of the dietary supplement, as required by 21 CFR 111.70(c)(1).

Specifically, after review of your master manufacturing record (MMR) and production formula by our investigator, the following deficiencies were noted:

a) For Tanalbit capsules, you informed our investigator that you did not establish or have documentation of in-process specifications for the (b)(4) step, such as (b)(4) time and speed, or the (b)(4) step following the (b)(4) step and before the (b)(4) step, such as (b)(4) time, temperature, weight, or percent moisture.

b) For Tabit capsules, you informed our investigator that you did not establish or have documentation of in-process specifications for the (b)(4) process step using (b)(4), such as treatment method and time.

We reviewed your response dated March 27, 2013, and have determined it is inadequate. Your response states that you “are currently editing [y]our MMR for Tanalbit and Tabit and anticipate its completion in one week” and refers us to your work in progress in attachments 5A-5F. However, you have not provided adequate in-process specifications. For example, attachments 5A-5C, which constitute your “Production Formula and Records” for your Tanalbit product, describe the general process but do not contain in-process specifications to help ensure that your finished product specifications will be met. Part of the process description includes the following statements: “(b)(4)” and “(b)(4).” A specific end point is not provided. Simple visual examination cannot assure uniform blending.

5. Your firm failed to establish and follow written procedures for the responsibilities of quality control operations, including written procedures for conducting a material review and making a disposition decision, and for approving or rejecting any reprocessing, as required by 21 CFR 111.103. Your firm also failed to make and keep records of these procedures, as required by 21 CFR 111.140(b)(1). Specifically, you informed our investigator that you did not establish any written procedures for the responsibilities of quality control operations, including those with respect to conducting a material review and lot disposition.

We reviewed your response dated March 27, 2013, and have determined it is inadequate. Your response included your “Intensive Nutrition Employee (b)(4)” document, which you characterized as a work in progress, and which consists of a list of duties of the Quality Control Manager. Your response did not include procedures for carrying out the listed duties.

6.Your firm failed to establish written procedures for packaging and labeling operations, as required by 21 CFR 111.403. Your firm also failed to make and keep records of the written procedures for packaging and labeling operations, as required by 21 CFR 111.430(b). Specifically, you informed our investigator that you have not established procedures and have no record of written procedures on how you conduct packaging and labeling operations for dietary supplements, including Tanalbit and Tabit capsules, that you manufacturer at your firm.

We reviewed your response dated March 27, 2013, and have determined it is inadequate because you did not provide written procedures for packaging and labeling operations. While you stated that you are writing your procedures and SOPs for packaging and labeling, and that you anticipated completion of SOPs and training in this area within two weeks, you did not submit this documentation for us to evaluate.

Misbranded Dietary Supplements

Your Tabit dietary supplement product is misbranded under section 403 of the Act [21 U.S.C. § 343] because it does not comply with FDA’s labeling regulations under 21 CFR Part 101. If your Tanalbit product did not have disease claims, which make this product a drug, it would also be misbranded for the same reason.

1.Your Tanalbit and Tabit dietary supplement products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] in that the declaration of nutrition information is not in accordance with 21 CFR 101.36, 101.9(b), and 101.12(b), Table 2. The declared serving size for these products is 1 Capsule. However, 21 CFR 101.36(b)(1)(i) and 101.9(b) requires that serving size be determined from the Reference Amounts Customarily Consumed (RACC) at 21 CFR 101.12(b). The RACC for Dietary Supplements is the maximum amount recommended, as appropriate, on the label for consumption per eating occasion. You have directions on your product label for your products that recommend “2-3 capsules 3 times daily before meals” (Tanalbit) and “2 capsules three times daily” (Tabit) The declared serving size is incorrect because it is less than the RACC for these dietary supplements; therefore, the declared quantitative amount by weight per serving for each dietary ingredient is also incorrect.

The above violations are not intended to be an all-inclusive list of violations at your facility and in your labeling. It is your responsibility to ensure that all of your firm’s products are in compliance with federal laws and regulations. You should take prompt action to correct the violations cited in this letter and to prevent their reoccurrence. Failure to do so may result in legal action without further notice, including seizure or injunction.

We also have the following comments:

You stated to our investigator that the water that is used as a component in your Tanalbit product is from (b)(4). In your response letter dated March 27, 2013, you stated that as of March 18, 2013, you would be using bottled, distilled water from a third party vendor as a component of your dietary supplement products. Please note that under 21 CFR 111.15(e)(2), water that may become a component of a dietary supplement must, at a minimum, comply with applicable federal, state, and local requirements and not contaminate the dietary supplement. 21 CFR 111.23(c) states that a manufacturer must make and keep records showing that water that may become a component of a dietary supplement meets this minimum standard. Additionally, 21 CFR 111.70(b) requires a manufacturer to establish specifications for each component it uses in the manufacture of a dietary supplement. When water is used as a component in the manufacture of a dietary supplement, a manufacturer may establish, as a specification, that the water meet the requirements in 21 CFR 111.15(e)(2). (Note that there are federal requirements for bottled water, which may be found in 21 CFR 165.110.) Alternatively, a manufacturer may establish, as a specification, that the water meet a more rigorous standard (e.g., be distilled or sterile), as appropriate. [See 72 Fed. Reg. 34752, 34814-17 (Jun. 25, 2007).]

You stated to our investigator that the shelf life of a product is usually (b)(4) from the date that the powder is ready for encapsulation. Please note that any expiration date, shelf life, shelf life dating, or “Best by” date you place on a product label should be supported by data. [See 72 Fed. Reg. 34752, 34856 (Jun. 25, 2007).]

Within fifteen (15) working days from your receipt of this letter, please notify this office in writing of the specific steps you have taken to correct the violations noted above. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. Please include copies of any available documentation demonstrating corrections have been made. If corrective action cannot be completed within fifteen (15) days, state the reason for the delay and the time frame within which the corrections will be completed.

Section 743 of the Act [21 U.S.C. § 379j-31] authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [ 21 U.S.C. § 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection-related costs.

Please send your reply to:

Lawton W. Lum

Director, Compliance Branch

U.S. Food and Drug Administration

San Francisco District

1431 Harbor Bay Parkway

Alameda, CA 94502

Please reference the CMS number 395974 in your reply.

If you have any questions regarding any issue in this letter, please contact Juliane Jung-Lau, Compliance Officer, at 510-337-6793.